Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

NCT ID: NCT05892471

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-09-01

Brief Summary

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Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ciprofol

Group Type EXPERIMENTAL

ciprofol injection

Intervention Type DRUG

Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia

propofol

Group Type PLACEBO_COMPARATOR

Propofol injection

Intervention Type DRUG

Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia

Interventions

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ciprofol injection

Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia

Intervention Type DRUG

Propofol injection

Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo Comparator

Eligibility Criteria

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Inclusion Criteria

1. Elective surgery patients
2. Aged 55 to 75
3. New York Heart Association class II or III cardiac functions
4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.

Exclusion Criteria

1. With a history of benzodiazepine allergy
2. Significant liver or kidney insufficiency
3. Coagulation dysfunction
4. Neurological or psychiatric disorders
5. Undergone major surgery within the past three months.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Le Yu

OTHER

Sponsor Role lead

Responsible Party

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Le Yu

Clinicians

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Handong Sun

Role: STUDY_DIRECTOR

Shanghai East Hospital of Tongji University

Locations

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Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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LE YU

Role: CONTACT

19921875120

Facility Contacts

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Le Yu, MM

Role: primary

19921875120

Other Identifiers

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2022.8.1-2023.8.1

Identifier Type: -

Identifier Source: org_study_id

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